In March 2016, the organization filed a “patent opposition” to prevent American pharmaceutical company Pfizer from being given a patent for the pneumococcal conjugate vaccine (PCV13), so that more affordable versions of the vaccine can become available in developing countries.
Doctors Without Borders (Medicins Sans Frontieres, or MSF) is now challenging Pfizer’s patent in a pre-grant opposition – a form of citizen review at the patent examination stage – to show the lack of technical merit of Pfizer’s patent application.
The organization claims that adding six serotypes to a widely-used carrier protein (CRM197) in order to conjugate 13 serotypes of streptococcus pneumonia into a single carrier is an obvious step with vaccine developers.
In addition, Doctors Without Borders believes that Pfizer’s application does not provide sufficient evidence to support its claims. An equivalent patent to the one opposed in India was already rejected by the European Patent Office (EPO) in December 2014 (EP1868645) and is also being challenged in South Korea.
Doctors Without Borders wants to highlight the pricing of the pneumonia vaccine, which Pfizer is marketing as Prevenar 13 in many developing countries. At the lowest global price, it is currently 68 times more expensive to fully vaccinate a child then in 2001, according to the 2015 MSF report “The Right Shot: Bringing down Barriers to Affordable and Adapted Vaccines.”
A pneumonia vaccine now accounts for almost half the price of the full vaccination of a child in some of the poorest countries.
“The pneumonia vaccine is the world’s best-selling vaccine, and last year alone, Pfizer brought in more than $6 billion dollars in sales just for this product – meanwhile many developing countries, where millions of children risk getting pneumonia, simply can’t afford it,” Dr. Greg Elder, medical coordinator for Doctors Without Borders Access Campaign, said in a press release.
“To make sure children everywhere can be protected from deadly pneumonia, other companies need to be allowed to enter the market so they can supply this vaccine for a much lower price than Pfizer charges,” he said.
One Indian vaccine producer has announced that it could manufacture and supply the vaccine for only $6 per child – for all three doses – which means a reduction of nearly almost half of the current $10 price per child.
“The pneumonia vaccine clearly does not merit patenting under India’s Patents Act and would only result in artificially prolonging Pfizer’s market monopoly, which keeps millions of children at risk of contracting this deadly killer,” said Leena Menghaney, head of Doctors Without Borders Access Campaign in South Asia.
“India must rebuff demands from pharmaceutical companies, and tackle low-quality patent applications which only add trivial technical changes and often deprive millions of people from accessing more affordable treatment and vaccines. Pfizer’s unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced,” Menghaney said.
Pneumonia, the leading cause of death among children, is responsible for almost 1 million deaths annually. Besides Pfizer, the only other company currently manufacturing the vaccine is GlaxoSmithKline (GSK).
The campaign’s claim is that the two companies could prevent a much larger number of these deaths if they allowed a broader use of the vaccine, potentially reducing yearly antibiotic use in children by 47 percent consecutively. The claims are grounded in a Doctors Without Borders analysis conducted in 75 countries to understand the reasons behind the global rise of antibiotic resistance.